Blog
Introducing the RWE Alliance: How a cross-industry coalition aims to advance RWE policy
The last several years have been foundational in the effort to advance the use of ...
Blog
How leading-edge teams are using RWE to accelerate drug development: A conversation with Janssen R&D and Sanofi
The majority of biopharma organizations are investing in real-world evidence (RWE) ...
Blog
How payers and providers can leverage RWE: Q&A with Bill Guptail, SVP of Value-Based Care, Aetion
As payers and providers continue to navigate value-based agreements and strive to improve ...
Publication
Evaluating the Utility of Synthetic COVID-19 Case Data
Blog
How using an RWE platform can support building regulatory-grade ECAs
An external control arm (ECA) study is a cutting-edge pharmacoepidemiologic design that ...
Blog
RWE plays an integral role in NICE’s five-year strategy
For the UK’s National Institute for Health and Care Excellence (NICE) the COVID-19 ...
Blog
How RWE can support safety in Europe: Dr. Pierre Engel on leveraging innovative strategies to meet regulatory requirements
In Europe as in the U.S., biopharma organizations, regulators, and health technology ...
Publication
Can Synthetic Data Be A Proxy For Real Clinical Trial Data? A Validation Study
Blog
Research spotlight: Using RWE to assess molecular insights, published in Science
Earlier this year, Aetion co-authored a study published in Science that demonstrates how ...
Blog
Leveraging RWE in regulatory submissions of medical devices: Three takeaways for medical device and diagnostic companies
The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological ...
Blog
Research spotlight: Using RWD to evaluate risk of COVID-19 reinfection
To date, approximately 66 million patients have recovered from COVID-19, globally. As the ...
FDA Decision Alert
CDER-Approved NDA for VEKLURY® (remdesivir)
On October 22, 2020, the FDA approved Gilead Sciences’s VEKLURY® (remdesivir) for the ...
Blog
Research spotlight: Understanding and correcting bias in RWE studies
Real-world evidence (RWE) studies are often criticized for their susceptibility to ...
Blog
How RWE can support drug development during COVID-19 and beyond: Q&A with Dr. Diana Brainard of Gilead Sciences
The COVID-19 pandemic introduced novel challenges for global biopharma organizations, as ...
Blog
How RWE can advance understanding of—and boost public confidence in—COVID-19 vaccine safety
After nearly one year of suffering, isolation, and economic downturn on an unprecedented ...
Blog
Opportunities to advance RWE in Europe: Assessing today’s landscape and priorities for future guidance
Real-world evidence (RWE) has emerged as an important tool for global regulators, health ...
Blog
How medical device companies can use RWE to drive impact for patients: Q&A with Christian Howell, Aetion’s VP/GM of Medical Devices and Diagnostics
For medical device manufacturers, real-world data (RWD) and real-world evidence (RWE) are ...
Blog
Sourcing global real-world data to support R&D: Q&A with Ian Rentsch, VP of Growth and Strategic Partnerships, Aetion
Biopharma organizations are working to incorporate real-world evidence (RWE) throughout ...
Blog
Real-world data in the era of COVID-19: Expert perspectives on the changing data landscape
The COVID-19 pandemic has brought forth a new era of collaboration between health care ...
Blog
Applying regulatory experience in the technology space: Q&A with Lowell Schiller, Chief Legal and Regulatory Officer at Aetion
Lowell Schiller, J.D., recently joined Aetion as Chief Legal and Regulatory Officer, ...
FDA Decision Alert
EMA-Approved application for ZOLGENSMA® (onasemnogene abeparvovec-xioi)
On March 26, 2020, the European Medicines Agency (EMA) approved AveXis’s ZOLGENSMA® ...
Blog
Research spotlight: Using RWE to evaluate complications of COVID-19
While COVID-19 is primarily a respiratory disease, its impact has also been associated ...
Blog
Interim results of the RCT-DUPLICATE Project: Dr. Jessica Franklin on learnings thus far
The RCT-DUPLICATE project began in 2018 with the goal of informing the use of real-world ...
FDA Decision Alert
CDER-Approved NDA for EVRYSDI™ (risdiplam)
On August 7, 2020, the FDA approved Genentech’s EVRYSDI™ (risdiplam) “for the treatment ...